The goal of this Phase II SBIR project is to continue development of an exciting platform based on integration of optical coherence tomography acquisition with real-time 3D spatial localization. In Phase I, in the context of gynecological diagnostic imaging, we demonstrated hardware and software for prototype image fusion between colposcopic/intravaginal imaging and OCT images of the cervix. We also demonstrated a promising methodology for simplified acquisition of 3D OCT data sets which may have broad application. In this project, we build upon these promising results to define and develop two new products. The first will be a clinical tracking and software system which augments an OCT imaging system to provide fusion between OCT and colposcopic images as well as tools for analyzing, reviewing, and reporting image findings. The second will consist of software and an imaging/tracking probe which can be readily coupled (by an end user) to commercially available OCT systems and which, when installed, will allow reconstruction of 3D OCT datasets from simple manually scanned 2D data. Devices will be validated in phantoms and animal models as well as clinically. While this application continues to be focused on gynecological diagnosis, we will also lay important experimental groundwork for future development of this technology in other fields. PUBLIC HEALTH RELEVANCE: In 2010, approximately 12,200 cases of invasive cervical cancer are expected to be diagnosed in the United States, and it is estimated that incidence of noninvasive cervical cancer (carcinoma in situ) is about four times as high [://www.cancer.gov/cancertopics/types/cervical]. Approximately 4,210 women are expected to die from cervical cancer in the United States during 2010. Though mortality rates associated with cervical cancer have decreased dramatically over the last 50 years, the incidence of cervical precancers has increased, and it has been suggested that without improvement in current screening and diagnostic techniques, mortality rates associated with cervical carcinoma could increase, especially if human papilloma virus (HPV) seroprevalence continues to rise. Early detection of cervical precancerous lesions can have a dramatic impact on cervical cancer mortality rates, increasing five- year survival rates from 70% to about 100%. This project focuses on development of a novel imaging system for improving diagnosis and characterization of cervical tissue. The developed technology also has wide application in other diagnostic fields including cardiology, laparoscopy, and gastroenterology.